The following data is part of a premarket notification filed by Fresenius Kabi Ag with the FDA for Amicus Separator System.
| Device ID | K200530 |
| 510k Number | K200530 |
| Device Name: | AMICUS Separator System |
| Classification | Separator, Automated, Blood Cell, Diagnostic |
| Applicant | Fresenius Kabi AG 3 Corporate Drive Lake Zurich, IL 60047 |
| Contact | Kim Forch |
| Correspondent | Kim Forch Fresenius Kabi AG 3 Corporate Drive Lake Zurich, IL 60047 |
| Product Code | GKT |
| CFR Regulation Number | 864.9245 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-02 |
| Decision Date | 2020-09-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810020440232 | K200530 | 000 |
| 00810020440249 | K200530 | 000 |
| 00810020440218 | K200530 | 000 |